Study of Sonazoid™ in patients under the age of 18

Phase 4

• Conditions: Focal liver lesions; Cancer

• Registration Number: ISRCTN17927667
• Lead Sponsor: GE HealthCare Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-18
• Last Update Posted: 22 July 2024
• Study Completion: 2025-11-29

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. The subject is <18 years of age on the day of consent
2. The subject has at least 1 untreated FLL with =8 lesions (excluding cysts), with =10 cm confirmed in a diagnostic examination performed in the past month (or past 3 months if the lesion was benign) and that could be visualised by unenhanced (not contrast-enhanced) US imaging.
3. The subject has had a dynamic CECT or CEMRI examination within the past month or was scheduled to have one in the month following inclusion in the study and the original images (or copies thereof) are/would be available.
4. The subject can comply with study procedures.
5. Parents or legally authorised representatives have signed the Informed Consent Form approved for this study by the Ethics Committee. The form will indicate that the patient (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study. Patients who are able to provide assent have signed an age-appropriate paediatric assent form.
6. Post-menarcheal female patients must have a negative urine pregnancy test at screening and at pre-dose on the dosing day.
7. Post-menarcheal female patients and male patients who are sexually active with a partner of childbearing potential must be practicing abstinence or be using an effective form of birth control (See Section 8.6) for =30 days before being enrolled in the study.

Exclusion Criteria

1. The subject has a known or suspected hypersensitivity to any of the components of Sonazoid™, including a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral or laryngeal swelling, hypotension, or shock).
2. The subject has an acute clinically fatal condition (i.e., the expected survival is =6 months).
3. The subject has previously received Sonazoid™ or another ultrasound contrast agent within the past 30 days.
4. The subject has undergone or was undergoing systemic or loco-regional chemotherapy or radiation therapy.
5. The subject is participating in another clinical trial with an unregistered medicinal product, or less than 30 days has passed since the subject completed participation in such a trial.
6. The subject is a pregnant or lactating female or is a female of childbearing potential not using an acceptable form of birth control (negative urine pregnancy test also required).
7. The physician judges that a large-enough needle (24-gauge or larger) cannot be inserted.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The accuracy, sensitivity and specificity of the diagnosis based on the independent blinded read of the Sonazoid™-enhanced imaging for lesion differentiation (benign or malignant FLLs) during vascular phase imaging. The WFUMB-EFSUMB guidelines for interpreting CEUS of the liver in adults shall be used for interpreting the images and the subject’s baseline diagnosis (well-established by CECT, CEMRI or biopsy) will be used as the reference diagnosis/standard of truth.